New Australian site opening for DEP® trials
Jul 9th, 2020
Starpharma today announced the opening of a new trial site for the phase 2 DEP® irinotecan trial, at the Kinghorn Cancer Centre in Sydney. The DEP® irinotecan trial is also being conducted at multiple leading UK cancer centres including The Christie, The Royal Marsden, Newcastle Freeman Hospital, and The Beatson West of Scotland Cancer Centre. The Kinghorn Cancer Centre will also be opened shortly as an additional site for the phase 2 DEP® cabazitaxel trial.
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Pandemic a catalyst for boosting commercial outcomes, says Starpharma CEO
Jul 3rd, 2020
The Age recently interviewed Starpharma CEO Dr Jackie Fairley to discuss how the COVID19 pandemic could be the catalyst for the pharmaceutical industry to improve the way they convert important research into commercial products. The article highlighted Starpharma’s recent activities in response to the pandemic, including the development of a product using its existing anti-viral dendrimer SPL7013.
To read the full article, click here.
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DEP irinotecan boosts immuno-oncology in colon cancer models
Jun 29th, 2020
Starpharma today announced its SN-38 nanoparticle, DEP® irinotecan in combination with an immuno-oncology (IO) agent (anti PD-1 antibody) showed superior anti-tumour activity and significant survival benefit in two colorectal cancer (CRC) models when compared to the anti PD-1 antibody alone. These results included improvement in both survival and efficacy in the particularly aggressive CT-26 CRC model.
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Starpharma CEO Dr Jackie Fairley on the ABC’s 7.30 report
Jun 25th, 2020
Alan Kohler recently interviewed Starpharma CEO Dr Jackie Fairley on the ABC’s 7.30 report to discuss the importance of developing other methods of protection against COVID-19 while we wait for a vaccine. Jackie also discusses how Starpharma’s patented dendrimer SPL7013 is being developed for use in an antiviral nasal spray to prevent COVID-19 infection.
Watch the full interview here: https://www.abc.net.au/7.30/how-long-will-the-economy-take-to-recover/12394342
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Multiple DEP® products showcased at AACR 2020
Jun 23rd, 2020
Starpharma today announced that five posters featuring products based on Starpharma’s DEP® platform have been presented at the AACR (American Association for Cancer Research) Annual Meeting. The AACR Annual Meeting brings together leading cancer research and medicine from institutions all over the world and is an important forum for both raising product awareness and commercial interactions.
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Starpharma to present at OTCQX Virtual Investor Conference
Jun 18th, 2020
Starpharma today announced that a pre-recorded presentation by Dr Jackie Fairley, CEO, will be broadcast on Thursday 18 June 2020 (US ET) as part of OTCQX’s Virtual Investor Conference for Global Mid-cap and Large-cap Companies. The conference is primarily attended by US-based retail investors, as well as advisors.
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DEP® lutetium effective in human prostate cancer model
Jun 17th, 2020
Starpharma today announced results from its first radiotherapeutic candidate, DEP® lutetium. DEP® lutetium is a patented nanoparticle which incorporates the radioisotope Lutetium-177 on a DEP® dendrimer scaffold.
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VivaGel® BV launched in central and eastern European countries
Jun 16th, 2020
Starpharma today announced that VivaGel® BV has been launched in Central and Eastern European (CEE) region. This launch follows European launches in Germany, UK and several other European countries.
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Shareholder Update May 2020
May 14th, 2020
In this issue:
>> VivaGel® BV launched in Asia
>> Fleurstat BVgel launched in NZ
>> DEP® irinotecan phase 2 commences after positive phase 1 results
>> SPL7013 against SARS-COV-2 (coronavirus)
>> Fleurstat BVgel ranks as #1 topical BV treatment
>> Okamoto adds 11 more Asian countries to licence
>> US regulatory update
>> COVID-19: Starpharma’s operations continue with minimal disruption
>> DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan
>> DEP® patient case studies
>> AstraZeneca’s DEP® trial ongoing in the US & US$3 million milestone payment received
>> New DEP® ADC programs
>> DEP® pipeline targets multiple high-value areas
>> Other DEP® programs
>> Outlook, recent news & events
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DEP® irinotecan phase 2 commences after positive phase 1 results
May 7th, 2020
Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP® irinotecan. The trial met its objective of evaluating safety, tolerability, pharmacokinetics and preliminary efficacy data, and identifying a recommended phase 2 dose. The trial will now transition seamlessly into phase 2, with recruitment activities underway at three sites. Two additional sites, The Beatson West of Scotland Cancer Centre (the Beatson) and the Kinghorn Cancer Centre in Sydney are also expected to commence recruitment shortly.
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Starpharma presents at Macquarie Australia Conference
May 5th, 2020
Starpharma has been invited to present today at the Macquarie Australia Conference. Due to COVID-19, the Macquarie Australia Conference will be a virtual conference for registered institutional investors. The event will provide international and domestic institutions with the opportunity to hear from a range of invited Australian companies over three days. Starpharma is one of a handful of companies in the pharmaceutical/biotech and healthcare industries to be presenting during the conference.
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SPL7013 shows significant activity against SARS-CoV-2 (coronavirus)
Apr 15th, 2020
Starpharma today announced that its proprietary VivaGel® active, astodrimer sodium (SPL7013), has been shown in laboratory studies to have significant antiviral activity against the coronavirus that causes COVID-19 (coronavirus disease). SPL7013 inhibited the infection of cells with the SARS-CoV-2 virus and the finding was validated by replicate testing against a positive control compound, remdesivir (Gilead), which is considered a leading candidate for the treatment of COVID-19. The finding was also significant given that SPL7013 was reported to be the best performing test compound against SARS-CoV-2 in the laboratory’s assay to date. With these positive results, Starpharma is evaluating product concepts and formulation options for SPL7013, which may have potential applications in the prevention and management of COVID-19.
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Quarterly Cashflow and Activity Report
Apr 7th, 2020
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2020.
Starpharma’s cash balance as at 31 March 2020 was $36.1 million, an increase of $0.2 million compared to the previous quarter’s cash balance. Net operating cash outflows for the quarter were $0.9 million, or $6.0 million for the nine months to 31 March 2020. Starpharma’s strong cash reserves and clean balance sheet places the Company in a strong position to continue to progress its commercial and R&D activities in the current uncertain global environment of the COVID-19 pandemic.
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Okamoto licenses VivaGel® antiviral condom in Asian countries
Mar 4th, 2020
Starpharma today announced that following the successful launch of the VivaGel® antiviral condom by Okamoto Industries, Inc. (TYO: 5122:JP; Okamoto) in Japan, Okamoto has sought an expansion to its licence territory for the VivaGel® condom. As a result, Starpharma has granted Okamoto marketing rights to a further 11 countries in Asia which include South Korea, Indonesia, Malaysia, Thailand, Singapore and the non-government China market.
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Starpharma appoints David McIntyre and Appendix 3X
Mar 2nd, 2020
Starpharma today announced that Mr David McIntyre has commenced as an independent non-executive director of Starpharma, effective 1 March. Mr McIntyre’s appointment follows a comprehensive Board renewal and search process. As advised at the Company’s last AGM, Mr Richard Hazleton will be retiring at the 2020 AGM in November, having served 13 years on the Company’s Board. The timing of Mr McIntyre’s appointment enables a smooth transition and handover between directors.
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Interim Report and Half-Year Financial Results
Feb 24th, 2020
Starpharma today released its interim report and financial results for the half-year ended 31 December 2019.
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VivaGel BV launched in Asia
Feb 13th, 2020
Starpharma today announced that VivaGel® BV has been launched in Asia under the brand name BETADINETM BV Gel. The product has initially been launched in South East Asia, with further roll-out in additional Asian countries, as regulatory approvals are granted.
BETADINETM BV Gel will be available over-the-counter (OTC), without the need to see a doctor or obtain a prescription. Asia is the third region to launch VivaGel® BV and represents a large commercial opportunity with access to more than 1.5 billion women.
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David McIntyre appointed as non-executive director
Feb 12th, 2020
The Board of Starpharma is pleased to announce the appointment of Mr David McIntyre as an independent non-executive director, effective 1 March 2020.
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Starpharma receives US$3M milestone from AstraZeneca
Feb 11th, 2020
Starpharma today announced it has received US$3 million (A$4.5 million) from AstraZeneca following the successful dosing of the first patient in the phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) in December.
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Shareholder Update January 2020
Jan 30th, 2020
In this issue:
>> VivaGel® BV launched in the UK
>> AstraZeneca first DEP® product enters the clinic; triggers US$3M milestone
>> DEP® cabazitaxel trial moves into phase 2 on positive results
>> Fleurstat BVgel marketing campaign; New Zealand launch planned
>> Dual strategy to achieve approval of the NDA in the US
>> Okamoto joins forces with Japanese government for STI prevention campaign
>> VivaGel® condom receives regulatory approval in Europe
>> DEP® docetaxel & DEP® cabazitaxel clinical trial case studies
>> DEP® irinotecan phase 1/2 trial
>> New candidate - DEP® gemcitabine
>> GMP DEP® facility licence
>> DEP® combinations add further value
>> Outlook, recent news & events
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Quarterly Cashflow Report
Jan 29th, 2020
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2019.
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Commencement of phase 1 trial for AZD0466 utilising DEP®
Dec 30th, 2019
Starpharma today announced that AstraZeneca (LSE/STO/NYSE: AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) and the first patient has been successfully dosed. The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.
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Starpharma receives $4.9M R&D tax incentive refund
Dec 16th, 2019
Starpharma today announced that it has received a $4.9M R&D tax incentive refund which relates to the costs of research and development during the 2019 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including DEP® and VivaGel®.
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DEP® cabazitaxel progresses to phase 2 on positive results
Dec 10th, 2019
Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP® cabazitaxel. The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose of 20 mg/m2. The trial will now transition seamlessly into phase 2, with two new sites initiated and recruitment activities already underway.
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AGM Chairman’s address and CEO’s presentation
Nov 21st, 2019
Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 4.00pm today.
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VivaGel® condom receives regulatory approval in Europe
Nov 20th, 2019
Starpharma today announced that it has been granted marketing approval for the VivaGel® condom in Europe.
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2019 AGM details
Nov 19th, 2019
Starpharma today notifies that its 2019 AGM will be held at 4pm on 21 November 2019 at RACV City Club, Level 2, 501 Bourke Street, Melbourne, Victoria.
The AGM will be recorded and available via webcast later that day. To access the webcast, participants can register via the following link:
https://webcasting.boardroom.media/broadcast/5dccc1f06242591605116cb6
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UK launch of VivaGel® BV
Nov 13th, 2019
Starpharma today announced that VivaGel® BV has been launched in the UK under the brand Betafem® BV Gel. This launch follows the first European launches in June 2019, including in Germany and other countries.
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DEP® gemcitabine outperforms Gemzar® in human pancreatic cancer model
Oct 31st, 2019
Starpharma today announced results for its next internal development candidate, DEP® gemcitabine.
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Quarterly Cashflow Report
Oct 30th, 2019
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2019.
Starpharma’s cash balance as at 30 September 2019 was $36.8 million, with net operating cash outflows for the quarter of $4.6 million. The cash balance does not include the anticipated $4.9 million R&D tax incentive which is expected to be received during the December quarter.
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Starpharma to present at US Drug Delivery Conference
Oct 8th, 2019
Starpharma today announced that it has been invited once more to present at the 9th Annual Partnership Opportunities in Drug Delivery (PODD) conference in Boston, USA, on 7-8 October.
The PODD conference showcases the latest advances in drug delivery and provides networking opportunities with senior scientific and commercial executives from many of the major international pharmaceutical companies. This year’s PODD conference will be chaired by AstraZeneca’s Head of Drug Delivery, Dr Shawn Davis.
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FDA Authorisation of First-in-Human Clinical Trial with AstraZeneca’s DEP® product AZD0466
Sep 26th, 2019
Starpharma today announced that that the U.S. Food and Drug Administration (FDA) has authorised the use of AstraZeneca’s DEP® Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug (IND) application. This is the first DEP® candidate to reach this milestone from Starpharma’s multiproduct license with AstraZeneca.
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DEP® irinotecan synergistic with Lynparza® in refractory human colon cancer model
Sep 12th, 2019
Starpharma today announced that its patented clinical stage nanoparticle formulation, DEP® irinotecan, showed significantly enhanced efficacy benefits over standard irinotecan (Camptosar®) and olaparib (Lynparza®) alone and in combination, in an irinotecan-refractory HT-29 human colon cancer xenograft model.
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VivaGel® BV regulatory approvals continue in Asia
Sep 3rd, 2019
Starpharma today announced that it has received a further regulatory approval in an Asian country for VivaGel® BV. This approval follows multiple country approvals in the region as previously announced on 15 August 2019. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.
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Positive results with Targeted DEP® using antibody fragment in human ovarian cancer model
Aug 29th, 2019
Starpharma today announced that treatment with a novel HER-2 Targeted DEP® conjugate from its internal Targeted DEP® program resulted in tumour regression and 100% survival in a preclinical human ovarian cancer model.
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Annual report and full year financial results
Aug 28th, 2019
Starpharma today released its annual report and financial results for the year ended 30 June 2019.
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Promising efficacy signals observed in ongoing DEP® trials, including DEP® cabazitaxel escalation phase
Aug 28th, 2019
Starpharma today announced that promising efficacy signals have been observed in its ongoing clinical trials for both DEP® cabazitaxel and DEP® docetaxel.
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First Asian Regulatory Approvals Received for VivaGel® BV
Aug 15th, 2019
Starpharma today announced that it has received the first regulatory approvals in South East Asia for VivaGel® BV. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.
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Starpharma commences phase 1/2 DEP® irinotecan trial
Aug 8th, 2019
Starpharma today announced that it has received the necessary regulatory and ethics approvals and will commence its phase 1/2 clinical trial for DEP® irinotecan. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® irinotecan to define a recommended phase 2 dose (RP2D), and to determine anti-tumour efficacy of the product in select tumour types. DEP® irinotecan is the third DEP® product to enter the clinic from Starpharma’s internal portfolio with a fourth, partnered DEP® candidate, AZD0466, also set to enter the clinic later this year.
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Quarterly Cashflow Report
Jul 16th, 2019
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2019.
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Shareholder Update July 2019
Jul 1st, 2019
In this issue:
>> VivaGel® BV launched in Europe & Australia; US regulatory progress
>> VivaGel condom launched in Japan by Okamoto
>> DEP® docetaxel & DEP® cabazitaxel clinical trial update; DEP® irinotecan trial start & new data
>> Starpharma signs second commercial oncology agreement with AstraZeneca
>> AstraZeneca highlights AZD0466 at 2019 ASCO meeting & upcoming US FDA IND
>> Patent published for AstraZeneca Bcl2/xL DEP conjugates
>> DEP® radiotherapeutics
>> Outlook, recent news & events
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VivaGel® BV launched in Europe
Jun 27th, 2019
Starpharma today announced that VivaGel® BV has been launched in Europe under the brand name Betadine BVTM. The product has been launched in several countries in Europe, including Germany, with further roll-out in additional European countries during the year.
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Starpharma presents at Macquarie Emerging Leaders Forum
Jun 20th, 2019
Starpharma has been invited to present at the Macquarie Emerging Leaders Corporate Forum in Melbourne. The Macquarie Emerging Leaders Corporate Forum provides Starpharma with an opportunity to present to more than 100 investors from Melbourne and Sydney.
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US patent granted for DEP Bcl2/xL inhibitor conjugates
Jun 12th, 2019
Starpharma announced the first patent for DEP® Bcl2/xL inhibitor conjugates, developed in collaboration with AstraZeneca, has been granted by the US Patent and Trademark Office. These patented DEP® Bcl2/xL inhibitor conjugates combine Starpharma’s innovative DEP® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitors, which are being investigated for treating various cancers, including leukemias.
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Okamoto launches VivaGel® condom in Japan
Jun 4th, 2019
Starpharma today announced that the VivaGel® condom has been launched in Japan under Okamoto’s leading and highly successful Zero Zero Three (003) brand. This is the first condom with antiviral coating in Japan and will also carry Starpharma’s VivaGel® brand.
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Starpharma signs second oncology agreement with AstraZeneca
Jun 3rd, 2019
Starpharma today announced a Development and Option Agreement with AstraZeneca (LON: AZN) to progress the development of a Dendrimer Enhanced Product (DEP®) version of an undisclosed AstraZeneca major marketed oncology medicine. This is the second DEP® commercial agreement Starpharma has signed with AstraZeneca, the first agreement being a multiproduct licence which covers novel oncology drug candidates such as AZD0466 (a Bcl2/xL inhibitor).
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Starpharma presents at UBS Healthcare Conference
May 29th, 2019
Starpharma has been invited to present today at the UBS Australian Emerging Companies Conference - Healthcare and Biotech – in Sydney. The UBS Healthcare Conference provides Starpharma with an opportunity to present to approximately 100 institutional investors.
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DEP® irinotecan combination outperforms in refractory human colon cancer model
May 24th, 2019
Starpharma today announced that its patented nanoparticle formulation, DEP® irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar®) and cetuximab (Erbitux®), in the irinotecan-refractory HT-29 human colon cancer model.
These impressive results were despite the fact that these standard colorectal cancer (CRC) treatments, Camptosar® and/or Erbitux®, showed limited activity in this preclinical model.
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Regulatory progress for VivaGel BV in the US
May 23rd, 2019
Starpharma has received formal feedback from the recent meeting held with the US FDA in relation to the approval for two related bacterial vaginosis (BV) indications - BV treatment and the prevention of recurrent BV in the United States.
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Starpharma to present at US Drug Delivery Conference
May 7th, 2019
Starpharma today announced that it will be presenting its DEP® platform at the 2nd Annual Drug Delivery West conference in San Francisco on 6-7 May 2019 (US time).
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